Events

Retiro De Equipo (Recall) de GE X-Ray Systems with CRT Video Monitor Suspensions

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por GE Medical Systems LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    15819
  • Fecha de inicio del evento
    2013-12-09
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    It has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. there is a potential that your system has not been installed per specified installation requirements. ge healthcare is not aware of any fall of the overhead monitor suspension; however, missing screws may increase the risk for fall of the monitor suspension. no injury has been reported due to this issue.
  • Acción
    Product to be modified

Device

GE X-Ray Systems with CRT Video Monitor Suspensions
  • Modelo / Serial
    Model: Precision 500D, Legacy, Prestilix, Monitrol ,RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII, Affected: All CRT Monitor suspension installed since Jan 1993 with products Precision 500D, Legacy, Prestilix, Monitrol ,RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC